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The Good News

THE GOOD
Approvals & Labels

Japan approves Sumitomo Pharma's Amchepry and Cuorips' ReHeart as world's first induced pluripotent stem cell therapies
Cell therapy, neurological, cardiovascular, iPS cells, Parkinson's disease, heart failure - Read more

AstraZeneca's Calquence (acalabrutinib) plus AbbVie's Venclexta (venetoclax) wins FDA approval for first-line chronic lymphocytic leukemia
Small molecule, cancer, BTK inhibitor, chronic lymphocytic leukemia, BCL-2 inhibitor, combination therapy - Read more

MHRA approves zanidatamab (Ziihera) targeting HER2 protein for advanced biliary tract cancer treatment
Antibody, cancer, monoclonal antibody, biliary tract cancer, HER2 target - Read more

Vanda Pharmaceuticals wins FDA approval for Bysanti (milsaperidone) targeting bipolar I disorder and schizophrenia
Small molecule, neurological, antipsychotic, bipolar disorder, schizophrenia, dopamine D2 antagonist - Read more

CStone Pharmaceuticals' sugemalimab wins UK MHRA approval for stage III non-small cell lung cancer
Antibody, cancer, monoclonal antibody, non-small cell lung cancer, PD-L1 inhibitor - Read more

THE GOOD
Business Development & Partnerships

Novartis divests 71% stake in Novartis India Limited to ChrysCapital consortium for $159M
Divestiture, generics, established brands, strategic transformation - Read more

LEON, Harro Höfliger announce strategic collaboration for global distribution of nanoencapsulation equipment
Strategic collaboration, nanoencapsulation, manufacturing, drug delivery, commercialization - Read more

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More Good News

THE GOOD
Clinical Trials

Virion Therapeutics reports sustained anti-hepatitis B virus immunity from single VRON-0200 dose in Ph1 study
Immunotherapy, infectious disease, T cell therapy, hepatitis B, checkpoint modifier, combination therapy - Read more

MoonLake Immunotherapeutics reports positive Ph2 results for sonelokimab targeting IL-17A/F in axial spondyloarthritis
Antibody, autoimmune, nanobody, axial spondyloarthritis, IL-17 inhibitor - Read more

Johnson & Johnson's TREMFYA (guselkumab) shows sustained remission through 3 years in ulcerative colitis extension study
Monoclonal antibody, autoimmune, ulcerative colitis, IL-23 inhibitor, long-term efficacy - Read more

THE GOOD
Fundraises

Candel Therapeutics lands $100M royalty deal to fund prostate cancer drug launch
Oncology, oncolytic virus, prostate cancer, clinical-stage - Read more

Herantis Pharma receives €8M ($9.4M) Horizon grant for Parkinson's disease HER-096 Phase 2 trial
Neurological, Parkinson's disease, clinical-stage, disease-modifying therapies - Read more

THE GOOD
Politics & Policy

Supreme Court strikes down Trump's emergency tariffs 6-3, ruling president overstepped authority under IEEPA
Regulatory, strategic, financial, operational - Read more

THE GOOD
Regulatory

Roche receives FDA decision date for giredestrant (giredestrant) targeting advanced breast cancer following Ph3 success
Small molecule, cancer, SERD, breast cancer, hormone therapy - Read more

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The Bad News

THE BAD
Clinical Trials

Ionis Pharmaceuticals terminates ION269 Ph1 trial for Alzheimer's disease in Down syndrome patients due to slow enrollment
Antisense oligonucleotide, neurological, Alzheimer disease, Down syndrome, amyloid plaques - Read more

Grail's Galleri multi-cancer early detection test fails primary endpoint in NHS trial of 142,000 participants
Diagnostic test, cancer, multi-cancer early detection, liquid biopsy, screening - Read more

THE BAD
Layoffs

Catalent cuts 96 more jobs in Maryland following reduced demand from large commercial customer
Gene therapy, rare disease, operational, cost reduction - Read more

THE BAD
Regulatory

FDA's Tracy Beth Høeg announces safety probes into antidepressants and RSV antibodies during pregnancy
Monoclonal antibody, neurological, operational, safety - Read more

THE BAD
Strategic Plans

Roche seeks to divest Rocephin antibiotic and Basel production facility amid generic competition
Divestment, infectious disease, manufacturing, antibiotic - Read more

Biohaven cuts R&D 60% after FDA rejection, pivots strategy to focus on obesity opportunities
Small molecule, neurological, strategic, cost reduction, operational - Read more

👹 The Ugly News 👹

THE UGLY
No Ugly News Today!

You’re all caught up on the latest Pharma & Biotech News!

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